Human medicines European public assessment report (EPAR): Zoledronic acid Mylan, zoledronic acid, Date of authorisation: 23/08/2012, Revision: 18, Status: Authorised

Zoledronic acid Mylan RSS Authorised This medicine is authorised for use in the European Union zoledronic acid Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview This is a summary of the European public assessment report (EPAR) for Zoledronic acid Mylan. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zoledronic acid Mylan. Expand section Collapse section What is Zoledronic acid Mylan? Zoledronic acid Mylan is a medicine that contains the active substance zoledronic acid. It is available as a 4-mg/5-ml concentrate for solution for infusion. Zoledronic acid Mylan is a ‘generic medicine’. This means that Zoledronic acid Mylan is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Zometa. What is Zoledronic acid Mylan used for? Zoledronic acid Mylan can be used to prevent bone complications in adults with advanced cancer that is affecting the bone. This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood). Zoledronic acid Mylan can also be used to treat the hypercalcaemia caused by tumours. The medicine can only be obtained with a prescription. How is Zoledronic acid Mylan used? Zoledronic acid Mylan must only be used by a doctor who has experience in the use of this type of medicine given into a vein. The usual dose of Zoledronic acid Mylan is one infusion of 4 mg over at least 15 minutes. When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D. A lower dose is recommended for patients with bone metastases (when cancer has spread to the bone) if they have mild to moderate problems with their kidneys. It is not recommended for patients with severe kidney problems. How does Zoledronic acid Mylan work? The active substance in Zoledronic acid Mylan, zoledronic acid, is a bisphosphonate. It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue. This leads to less bone loss. The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases. Patients with tumours can have high levels of calcium in their blood, released from the bones. By preventing the breakdown of bones, Zoledronic acid Mylan also helps to reduce the amount of calcium released into the blood. How has Zoledronic acid Mylan been studied? The company provided data from the published literature on zoledronic acid. No additional studies in patients were needed as Zoledronic acid Mylan is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Zometa. What are the benefits and risks of Zoledronic acid Mylan? Because Zoledronic acid Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s. Why has Zoledronic acid Mylan been approved? The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Mylan has been shown to have comparable quality and to be bioequivalent to Zometa. Therefore, the CHMP’s view was that, as for Zometa, the benefit outweighs the identified risk. The Committee recommended that Zoledronic acid Mylan be given marketing authorisation. Other information about Zoledronic acid Mylan The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Mylan on 23 August 2012. For more information about treatment with Zoledronic acid Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Zoledronic acid Mylan : EPAR - Summary for the public Reference Number: EMA/467454/2012 English (EN) (56.78 KB - PDF) First published: 10/09/2012 Last updated: 10/09/2012 View Other languages (21) български (BG) (117.33 KB - PDF) First published: 10/09/2012 Last updated: 10/09/2012 View español (ES) (58.56 KB - PDF) First published: 10/09/2012 Last updated: 10/09/2012 View čeština (CS) (85.03 KB - PDF) First published: 10/09/2012 Last updated: 10/09/2012 View dansk (DA) (57.16 KB - PDF) First published: 10/09/2012 Last updated: 10/09/2012 View Deutsch (DE) (76.11 KB - PDF) First published: 10/09/2012 Last updated: 10/09/2012 View eesti keel (ET) (56.71 KB - PDF) First published: 10/09/2012 Last updated: 10/09/2012 View ελληνικά (EL) (118.6 KB - PDF) First published: 10/09/2012 Last updated: 10/09/2012 View français (FR) (59.39 KB - PDF) First published: 10/09/2012 Last updated: 10/09/2012 View italiano (IT) (111.95 KB - PDF) First published: 10/09/2012 Last updated: 10/09/2012 View latviešu valoda (LV) (139.43 KB - PDF) First published: 10/09/2012 Last updated: 10/09/2012 View lietuvių kalba (LT) (105.92 KB - PDF) First published: 10/09/2012 Last updated: 10/09/2012 View magyar (HU) (101.42 KB - PDF) First published: 10/09/2012 Last updated: 10/09/2012 View Malti (MT) (84.89 KB - PDF) First published: 10/09/2012 Last updated: 10/09/2012 View Nederlands (NL) (78.19 KB - PDF) First published: 10/09/2012 Last updated: 10/09/2012 View polski (PL) (86.62 KB - PDF) First published: 10/09/2012 Last updated: 10/09/2012 View português (PT) (80.49 KB - PDF) First published: 10/09/2012 Last updated: 10/09/2012 View română (RO) (82.17 KB - PDF) First published: 10/09/2012 Last updated: 10/09/2012 View slovenčina (SK) (103.89 KB - PDF) First published: 10/09/2012 Last updated: 10/09/2012 View slovenščina (SL) (101.23 KB - PDF) First published: 10/09/2012 Last updated: 10/09/2012 View Suomi (FI) (78.27 KB - PDF) First published: 10/09/2012 Last updated: 10/09/2012 View svenska (SV) (55.86 KB - PDF) First published: 10/09/2012 Last updated: 10/09/2012 View Product information Zoledronic acid Mylan : EPAR - Product information English (EN) (235.96 KB - PDF) First published: 10/09/2012 Last updated: 31/03/2026 View Other languages (24) български (BG) (618.31 KB - PDF) First published: 10/09/2012 Last updated: 31/03/2026 View español (ES) (524.36 KB - PDF) First published: 10/09/2012 Last updated: 31/03/2026 View čeština (CS) (581.76 KB - PDF) First published: 10/09/2012 Last updated: 31/03/2026 View dansk (DA) (319.6 KB - PDF) First published: 10/09/2012 Last updated: 31/03/2026 View Deutsch (DE) (512.15 KB - PDF) First published: 10/09/2012 Last updated: 31/03/2026 View eesti keel (ET) (467.3 KB - PDF) First published: 10/09/2012 Last updated: 31/03/2026 View ελληνικά (EL) (599.61 KB - PDF) First published: 10/09/2012 Last updated: 31/03/2026 View français (FR) (355.88 KB - PDF) First published: 10/09/2012 Last updated: 31/03/2026 View hrvatski (HR) (437.75 KB - PDF) First published: 10/09/2012 Last updated: 31/03/2026 View íslenska (IS) (355.25 KB - PDF) First published: 10/09/2012 Last updated: 31/03/2026 View italiano (IT) (489.54 KB - PDF) First published: 10/09/2012 Last updated: 31/03/2026 View latviešu valoda (LV) (498.96 KB - PDF) First published: 10/09/2012 Last updated: 31/03/2026 View lietuvių kalba (LT) (607.72 KB - PDF) First published: 10/09/2012 Last updated: 31/03/2026 View magyar (HU) (620.57 KB - PDF) First published: 10/09/2012 Last updated: 31/03/2026 View Malti (MT) (616.16 KB - PDF) First published: 10/09/2012 Last updated: 31/03/2026 View Nederlands (NL) (480.73 KB - PDF) First published: 10/09/2012 Last updated: 31/03/2026 View norsk (NO) (565.91 KB - PDF) First published: 10/09/2012 Last updated: 31/03/2026 View polski (PL) (461.58 KB - PDF) First published: 10/09/2012 Last updated: 31/03/2026 View português (PT) (428.99 KB - PDF) First published: 10/09/2012 Last updated: 31/03/2026 View română (RO) (491.17 KB - PDF) First published: 10/09/2012 Last updated: 31/03/2026 View slovenčina (SK) (399.11 KB - PDF) First published: 10/09/2012 Last updated: 31/03/2026 View slovenščina (SL) (369.06 KB - PDF) First published: 10/09/2012 Last updated: 31/03/2026 View Suomi (FI) (450.41 KB - PDF) First published: 10/09/2012 Last updated: 31/03/2026 View svenska (SV) (461.64 KB - PDF) First published: 10/09/2012 Last updated: 31/03/2026 View Latest procedure affecting product information: N/0000339225 31/03/2026 This medicine’s product information is available in all official EU languages . Select 'available languages' to access the language you need. Product information documents contain: summary of product characteristics (annex I); manufacturing authorisation holder responsible for batch release (annex IIA); conditions of the marketing authorisation (annex IIB); labelling (annex IIIA); package leaflet (annex IIIB). Zoledronic acid Mylan : EPAR - All Authorised presentations English (EN) (14.4 KB - PDF) First published: 10/09/2012 Last updated: 28/08/2013 View Other languages (23) български (BG) (45.39 KB - PDF) First published: 10/09/2012 Last updated: 28/08/2013 View español (ES) (16.6 KB - PDF) First published: 10/09/2012 Last updated: 28/08/2013 View čeština (CS) (40.5 KB - PDF) First published: 10/09/2012 Last updated: 28/08/2013 View dansk (DA) (16.47 KB - PDF) First published: 10/09/2012 Last updated: 28/08/2013 View Deutsch (DE) (16.48 KB - PDF) First published: 10/09/2012 Last updated: 28/08/2013 View eesti keel (ET) (16.23 KB - PDF) First published: 10/09/2012 Last updated: 28/08/2013 View ελληνικά (EL) (43.88 KB - PDF) First published: 10/09/2012 Last updated: 28/08/2013 View français (FR) (16.42 KB - PDF) First published: 10/09/2012 Last updated: 28/08/2013 View íslenska (IS) (16.38 KB - PDF) First published: 10/09/2012 Last updated: 28/08/2013 View italiano (IT) (16.64 KB - PDF) First published: 10/09/2012 Last updated: 28/08/2013 View latviešu valoda (LV) (41.05 KB - PDF) First published: 10/09/2012 Last updated: 28/08/2013 View lietuvių kalba (LT) (38.87 KB - PDF) First published: 10/09/2012 Last updated: 28/08/2013 View magyar (HU) (42.02 KB - PDF) First published: 10/09/2012 Last updated: 28/08/2013 View Malti (MT) (51.18 KB - PDF) First published: 10/09/2012 Last updated: 28/08/2013 View Nederlands (NL) (16.64 KB - PDF) First published: 10/09/2012 Last updated: 28/08/2013 View norsk (NO) (16.39 KB - PDF) First published: 10/09/2012 Last updated: 28/08/2013 View polski (PL) (44.49 KB - PDF) First published: 10/09/2012 Last updated: 28/08/2013 View português (PT) (16.5 KB - PDF) First published: 10/09/2012 Last updated: 28/08/2013 View română (RO) (42.88 KB - PDF) First published: 10/09/2012 Last updated: 28/08/2013 View slovenčina (SK) (42.38 KB - PDF) First published: 10/09/2012 Last updated: 28/08/2013 View slovenščina (SL) (26.16 KB - PDF) First published: 10/09/2012 Last updated: 28/08/2013 View Suomi (FI) (16.44 KB - PDF) First published: 10/09/2012 Last updated: 28/08/2013 View svenska (SV) (16.29 KB - PDF) First published: 10/09/2012 Last updated: 28/08/2013 View Product details Name of medicine Zoledronic acid Mylan Active substance zoledronic acid International non-proprietary name (INN) or common name zoledronic acid Therapeutic area (MeSH) Fractures, Bone Anatomical therapeutic chemical (ATC) code M05BA08 Pharmacotherapeutic group Drugs for treatment of bone diseases Therapeutic indication Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone; treatment of adult patients with tumour-induced hypercalcaemia (TIH). Authorisation details EMA product number EMEA/H/C/002482 Generic This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines . Marketing authorisation holder Mylan Pharmaceuticals Limited Damastown Industrial Park Mulhuddart Dublin 15 Ireland Marketing authorisation issued 23/08/2012 Revision 18 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Zoledronic acid Mylan : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (145.95 KB - PDF) First published: 07/11/2025 Last updated: 31/03/2026 View Zoledronic acid Mylan : EPAR - Procedural steps taken and scientific information after authorisation (archive) English (EN) (129.79 KB - PDF) First published: 28/08/2013 Last updated: 07/11/2025 View Initial marketing authorisation documents Zoledronic acid Mylan : EPAR - Public assessment report Adopted Reference Number: EMA/550636/2012 English (EN) (235.87 KB - PDF) First published: 10/09/2012 Last updated: 10/09/2012 View CHMP summary of positive opinion for Zoledronic acid Mylan Adopted Reference Number: EMA/CHMP/417185/2012 English (EN) (71.39 KB - PDF) First published: 22/06/2012 Last updated: 22/06/2012 View Product information – with tracked changes The approved product information for this medicine is available below showing the changes since the previous procedure affecting the product information. The same document without tracked changes is above under 'Product information'. Zoledronic acid Mylan : EPAR – Product information - tracked changes English (EN) (379.5 KB - DOC) First published: 31/03/2026 View Other languages (24) български (BG) (161.06 KB - DOCX) First published: 31/03/2026 View español (ES) (154.15 KB - DOCX) First published: 31/03/2026 View čeština (CS) (233.43 KB - DOCX) First published: 31/03/2026 View dansk (DA) (170.61 KB - DOCX) First published: 31/03/2026 View Deutsch (DE) (143.08 KB - DOCX) First published: 31/03/2026 View eesti keel (ET) (160.13 KB - DOCX) First published: 31/03/2026 View ελληνικά (EL) (190.7 KB - DOCX) First published: 31/03/2026 View français (FR) (172.44 KB - DOCX) First published: 31/03/2026 View hrvatski (HR) (184.65 KB - DOCX) First published: 31/03/2026 View íslenska (IS) (176.37 KB - DOCX) First published: 31/03/2026 View italiano (IT) (167.99 KB - DOCX) First published: 31/03/2026 View latviešu valoda (LV) (209.48 KB - DOCX) First published: 31/03/2026 View lietuvių kalba (LT) (160.56 KB - DOCX) First published: 31/03/2026 View magyar (HU) (178.85 KB - DOCX) First published: 31/03/2026 View Malti (MT) (190.55 KB - DOCX) First published: 31/03/2026 View Nederlands (NL) (149.48 KB - DOCX) First published: 31/03/2026 View norsk (NO) (387 KB - DOC) First published: 31/03/2026 View polski (PL) (164.25 KB - DOCX) First published: 31/03/2026 View português (PT) (365 KB - DOC) First published: 31/03/2026 View română (RO) (177.99 KB - DOCX) First published: 31/03/2026 View slovenčina (SK) (181.93 KB - DOCX) First published: 31/03/2026 View slovenščina (SL) (188.27 KB - DOCX) First published: 31/03/2026 View Suomi (FI) (155.54 KB - DOCX) First published: 31/03/2026 View svenska (SV) (170.07 KB - DOCX) First published: 31/03/2026 View More information on Zoledronic acid Mylan Questions and answers on generic medicines Reference Number: EMA/393905/2006 Rev. 2 English (EN) (66.45 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View Other languages (22) български (BG) (93.16 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View español (ES) (68.3 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View čeština (CS) (87.71 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View dansk (DA) (66.79 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View Deutsch (DE) (67.55 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View eesti keel (ET) (65.21 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View ελληνικά (EL) (91.29 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View français (FR) (68.35 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View hrvatski (HR) (87.8 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View italiano (IT) (67.62 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View latviešu valoda (LV) (111.81 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View lietuvių kalba (LT) (86.76 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View magyar (HU) (85.76 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View Malti (MT) (89.35 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View Nederlands (NL) (66.81 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View polski (PL) (88.51 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View português (PT) (68.32 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View română (RO) (86.9 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View slovenčina (SK) (87.73 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View slovenščina (SL) (84.8 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View Suomi (FI) (66.21 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View svenska (SV) (67.11 KB - PDF) First published: 09/07/2007 Last updated: 07/12/2012 View Topics Generic and hybrid medicines Medicines This page was last updated on 31/03/2026 Share this page